Cleared Traditional

3M COLD/HOT WATER BAG AND WRAP (K791176) - FDA 510(k) Clearance

Class I General Hospital device.

K791176 · 3M Company · General Hospital
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Jul 1979
Decision
35d
Days
Class 1
Risk

K791176 is an FDA 510(k) clearance for the 3M COLD/HOT WATER BAG AND WRAP. Classified as Bottle, Hot/cold Water (product code FPF), Class I - General Controls.

Submitted by 3M Company (White City, US). The FDA issued a Cleared decision on July 30, 1979 after a review of 35 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6085 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all 3M Company devices

Submission Details

510(k) Number K791176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1979
Decision Date July 30, 1979
Days to Decision 35 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 129d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FPF Bottle, Hot/cold Water
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6085
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.